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Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Rauscher, Gregory E., M.D. PA.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01994681
First Posted: November 26, 2013
Last Update Posted: December 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Spectrosense Ltd.
Information provided by (Responsible Party):
Rauscher, Gregory E., M.D. PA
  Purpose
Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.

Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

Resource links provided by NLM:


Further study details as provided by Rauscher, Gregory E., M.D. PA:

Primary Outcome Measures:
  • Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population. [ Time Frame: Baseline ]
    An optimization algorithm will select VOCs that will provide maximal sensitivity and specificity.


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic Cancer
Healthy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with pancreatic cancer, biopsy confirmed, before treatment, ages above 18. vs. Healthy subjects without pancreatic cancer.
Criteria

Pancreatic cancer Group

Inclusion Criteria:

  • Age from 18 years old
  • Pancreatic cancer positive biopsy
  • Before any treatment
  • Signed Informed Patient Consent

Exclusion Criteria:

  • Age under 18 years old
  • Neoadjovant treatment
  • Post surgery for Pancreatic cancer
  • A history of any other cancer type, except skin cancer that is not melanoma

Healthy Group

Inclusion Criteria:

  • Healthy patients
  • No history of Pancreatic cancer
  • Signed Informed Patient Consent

Exclusion Criteria:

  • History of Pancreatic cancer
  • Pancreatic cancer background in the family
  • A history of any other cancer type, except skin cancer that is not melanoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994681


Contacts
Contact: Kevin Barga (551)996-8017 kbarga@hackensackumc.org

Locations
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Rauscher, Gregory E., M.D. PA
Spectrosense Ltd.
Investigators
Principal Investigator: Martin Gutierrez, MD Hackensack University Medical Center
  More Information

Responsible Party: Rauscher, Gregory E., M.D. PA
ClinicalTrials.gov Identifier: NCT01994681     History of Changes
Other Study ID Numbers: 00004108
First Submitted: November 20, 2013
First Posted: November 26, 2013
Last Update Posted: December 5, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases